EFFECT OF COLD SPINAL DOUCHE ON AUTONOMIC VARIABLES IN INDIVIDUALS WITH ESSENTIAL HYPERTENSION-A RANDOMIZED CONTROL TRIAL
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- To assess the effect of cold spinal douche on Blood Pressure and autonomic variables.
研究概览
简要总结
Spinal or Dorsal douche is a classical hydrotherapy technique that exerts its therapeutic effects primarily through its action on the central nervous system. Although not directly quoted, it is believed to influence blood pressure regulation and autonomic nervous system activity, as described in traditional literature. However, a thorough understanding of the physiological effects of spinal douche is essential before its integration into clinical practice. Hence, this study aims to investigate the impact of cold spinal douche on autonomic functions, to provide scientific evidence to support its mechanism of action and potential therapeutic applications.
Grouping: Subjects will be divided into 2 groups
2 GroupsGroup 1 (55) Group 2 (55)
MethodsThe institutional ethical clearance will be obtained prior to the conduct of the study. An informed consent will be obtained from the individuals by explaining the study objectives, methods, intervention and an informed consent will be obtained from every participant after an appraisal about the study protocol. All the rights of the individual pertaining to the study in their own language. After selecting the eligible subjects, Allotment will be done by using a Computer-generated random number
Group 1: Cold spinal douche for 5 mins (55)
Group 2: Cold water pouring for 5 mins (55)
Assessments will be done before the intervention (T0), immediately after the intervention (T1) and 30 minutes after the intervention (T2)
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 35.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects diagnosed with hypertension with or without medications.
- •Subjects who are diagnosed as Primary orEssential hypertension.
排除标准
- •Weak and debilitating individuals Hypertension with the CAD.
- •Hypertension with the previous stroke Hypertension with the CKD Hypertensive patients with ear infection, cervical spondylosis, renal or adrenal Involvement, increased glycemic profile, current abnormal thyroid functions and psychological conditions.
- •Female subjects during their menstrual cycle,.
结局指标
主要结局
To assess the effect of cold spinal douche on Blood Pressure and autonomic variables.
时间窗: baseline, immediately after the intervention,30 minutes after the intervention
次要结局
- To quantify the changes in Heart Rate Variability (HRV), Galvanic Skin Resistance (GSR)(baseline, immediately after the intervention,30 minutes after the intervention)
研究者
Padmashree K
SDM College of Naturopathy and Yogic Sciences